MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED (STERILE)

Model Number P40-002-0275-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

There was no report of any implant failure and the implant is still in the patient.Device history record was not reviewed because the implant lot number was not reported.The clinical image shows a 2nd digit with edema and mild erythema.The radiographic images show an oblique and ap view of the second digit with a hammertube implant in position according to the surgical technique guide.Fusion across the pipj is difficult to assess from the provided images, and must be clinically correlated.Good alignment and bone apposition across the pipj of the 2nd digit is appreciated.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

Patient reaction: swelling and skin irritation of the second phalanx was reported.The original surgery was (b)(6) 2021 where same device was used on both feet.No swelling on the left foot.No allege deficiency of product.Antibiotics was said to not have helped.The surgeon decided to leave the implant in and re-evaluated in 8 weeks and complete a culture test.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED (STERILE)
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7207165439
• MDR Report Key: 11758498
• MDR Text Key: 248401446
• Report Number: 3008650117-2021-00088
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K171715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P40-002-0275-S
• Device Catalogue Number: P40-002-0275-S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR